# GutSeer

Source: https://onco.cc/drugs/gutseer/  
OnCo record `gutseer` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Singlera and Fudan University's blood test for five digestive-system cancers, which found about eight in ten of them in hospital patients but flagged about one in eighteen people without cancer.

## Summary

In the GUIDE study (Huang et al., Molecular Cancer 2025; NCT05431621), GutSeer was trained and validated on 1,057 cancer patients and 1,415 controls (82.8% sensitivity, 95.8% specificity; colorectal 92.2%, oesophageal 75.5%, gastric 65.3%, liver 92.9%, pancreatic 88.6%) and then tested blind in 846 hospital inpatients and outpatients at five hospitals, with 81.5% sensitivity and 94.4% specificity; it also detected some advanced precancerous lesions of the colorectum, oesophagus and stomach. Singlera Genomics co-developed it. No regulatory status, availability or price was found.

## Fields

- Kind: Test
- Status: emerging
- Last checked: 2026-11-03
- Tags: test; mced; evidence:insufficient
- Brand: GutSeer
- Modality: Gastrointestinal multi-cancer blood test (cell-free DNA methylation and fragmentomics)
- Mechanism: A targeted bisulphite sequencing panel of 1,656 methylation markers, read together with fragment patterns, for five digestive cancers and their organ of origin.

## Notes

- Evidence grade insufficient for the claim that taking this test reduces late-stage diagnosis or cancer deaths: no randomised trial of it has reported either outcome, and its published performance comes from case-control or single-arm studies. The only randomised result for any multi-cancer test, NHS-Galleri, did not show fewer stage III or IV cancers.
- At about 94 to 96% specificity, roughly 1 in 20 people without cancer would test positive.
- What a result means: a positive result is a reason for further tests, not a diagnosis; a negative result does not rule cancer out and does not replace the screening tests that have been shown to work (bowel, breast, cervical and, where eligible, lung screening).

## Sources

- Huang et al., Molecular Cancer 2025 (GUIDE): https://doi.org/10.1186/s12943-025-02367-x
- ClinicalTrials.gov NCT05431621: https://clinicaltrials.gov/study/NCT05431621

## Connected records

- drugs: [EpiPanGI Dx](https://onco.cc/drugs/epipangi-dx/), [PanSeer](https://onco.cc/drugs/panseer/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Cell-free DNA methylation tests](https://onco.cc/technologies/cfdna-methylation-testing/), [cfDNA fragmentomics](https://onco.cc/technologies/fragmentomics/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/)
- companies: [Singlera Genomics](https://onco.cc/companies/singlera/)
- institutions: [Zhongshan Hospital, Fudan University](https://onco.cc/institutions/zhongshan-hospital-fudan/)
- trials: [GUIDE (molecular models for early diagnosis of digestive cancers, Zhongshan Hospital and Singlera)](https://onco.cc/trials/guide-gutseer/)
- key papers: [GUIDE: a prospective cohort study for blood-based early detection of gastrointestinal cancers using targeted DNA methylation and fragmentomics sequencing](https://onco.cc/key-papers/paper-gutseer-guide-mol-cancer-2025/)

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